Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

NCT00296153 | Completed Phase 4

• 2 other identifiers: CTN K85 05026Eudract no: 2005-005135-10
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)

Conditions

Human Immunodeficiency Virus; Ischemic Heart Disease

Keywords

Human immunodeficiency Virus (HIV); Highly Active Antiviral Therapy (HAART); Ischemic Heart Disease; OMACOR; Triglycerides; Endothelial function; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• The change from week 0 (baseline) to week 12 for: Plasma triglycerides

  baseline and 12 weeks

Secondary Outcomes (5)

• The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation

  baseline and 12 weeks

• HDL-cholesterol, LDL-cholesterol, total cholesterol

  baseline and 12 weeks

• Inflammatory parameters: ICAM, VCAM, sensitive CRP

  baseline and 12 weeks

• Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes

  baseline and 12 weeks

• Safety parameters

  baseline and 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Omacor 1000mg x 4 / day

Drug: Omega-3-acid ethyl esters 90

2

PLACEBO COMPARATOR

Drug: Omega-3-acid ethyl esters 90

Interventions

Omega-3-acid ethyl esters 90 DRUG

Omacor capsule 1000mg x 4 per day. Duration 12 weeks

Also known as: Omacor versus placebo

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man/women \> 18 years of age
• Documented HIV infection
• On active treatment with HAART for at least 3 months.
• Written informed consent. This implies that the patient can read and understand Danish or English

You may not qualify if:

• Age \< 18 years
• Malign disease
• Patients assessed as not cooperative
• Patients planning to be pregnant or who are already pregnant or breast feeding.
• Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
• Patients allergic to fish proteins
• Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months

Sponsors & Collaborators

• Pronova BioPharma: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Aalborg Hospital, Department of Nephrology

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Myocardial Ischemia

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jeppe H. Christensen, PhD

  Aalborg Hospital, Department of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: October 1, 2007
• Last Updated: March 11, 2008

Record last verified: 2008-03

Locations

DK (1)